The U.S. Department of Justice announced that 3M agreed to pay a settlement in the amount of $9.1 million for knowingly supplying the U.S. military with defective earplugs.
Written by Tracy Everhart
United States vs 3M Company
From 2003 to 2015 the 3M Company had a contract to supply earplugs to the United States military. The contract included a product that is known as the dual-ended Combat Arms Earplugs, Version 2 (CAEv2) which was standard issue to certain personnel during foreign conflicts. The Defense Criminal Investigative Service investigated allegations of a defective product and a petition was filed in the United States District Court in South Carolina on May 12, 2016.
This case was filed under the whistleblower provisions of the False Claims Act. The lawsuit alleged that 3M and its predecessor (Aearo Technologies, Inc) knew that the Combat Arms Earplugs were defective and did not inform the Defense Department prior to contracting with and selling products to the Defense Logistics Agency. They further alleged that these defective earplugs could directly impact the service members’ health and welfare, exposing millions to potential hearing loss and tinnitus.
Combat Arms Defect
The Combat Arms Earplugs, Version 2 (CAEv2) are double-ended earplugs that were designed as a non-linear or selective attenuation device. This means that the service member using them would be able to have two options for attenuation (noise canceling), depending on how the earplugs were worn.
What 3M did not divulge to the U.S. military, is that they (3M) knew that the CAEv2 was too short. They could not be inserted properly into the user’s ears and would loosen. This loosening was not perceived by the user and the earplug did not work as designed for some individuals.
An important note is that in 2012 3M issued a press release touting their contract with the U.S. Military to provide the CAEv2 earplugs. In this press release, they spoke about the importance of proper protection against excessive noise levels and how 3M was committed to protecting “warriors and workers from noise-induced hearing loss”.
They went on to state what happens when you are exposed to excessive levels of noise and do not have effective hearing protection. They stated that:
“Military personnel are exposed to excessive noise levels during combat and training on a variety of land, air and sea missions. This noise exposure has led many personnel to experience hearing loss and tinnitus, which is currently the number-one service-related disability for veterans. Tinnitus, often referred to as “ringing in the ears,” and noise-induced hearing loss can be caused by a one-time exposure to hazardous impulse noise, or by repeated exposure to excessive noise over an extended period of time.”
Hearing Loss and Tinnitus Among Veterans
In the United States, hearing impairments are the most common service-connected disabilities among military veterans. According to the Centers for Disease Control and Prevention (CDC), veterans, in general, are 30 percent more likely to experience severe hearing impairment (SHI) when compared to nonveteran adults. The CDC has also determined that veterans who served overseas during Operations Enduring Freedom and Iraqi Freedom (September 2001- March 2010) are four times more likely to experience SHI than nonveterans. This is during the same time in which the CAEv2 earplugs were standard issue to military personnel.
Research Findings
According to an article published in Epidemiologic Reviews, veterans of Operations Enduring Freedom, Iraqi Freedom, and New Dawn were exposed to numerous conditions (most notably high levels of noise) that could lead to hearing loss and tinnitus (the most common service-related disabilities among U.S. veterans).
The findings of their systemic review found 13 studies that presented data related to the prevalence of hearing loss and tinnitus and 4 studies related to risks and protective factors. They concluded that there is reason to believe that individuals that serviced in Operations Enduring Freedom, Iraqi Freedom, and New Dawn will have a greater likelihood of experiencing hearing health issues than those that did military service prior to these conflicts.
They hypothesized that this is most likely related to the fact that approximately 75% of the service member combat injuries during this time period were a result of blasts. They stated that the correlation was currently unknown due to the lack of research about the prevalence or effects of blast-related ear trauma. Since this article in Epidemiologic Reviews was published, the results of additional studies have been released that confirm these findings.
In 2016, a study was published in Scientific Reports. It describes what happens to the inner ear after a person is exposed to blast from an improvised explosive device (IED). They explain that the auditory system is the organ that is most commonly damaged by blast overpressure.
Similar injuries were seen following the Boston Marathon bombings and resulted in temporary and permanent hearing loss, tinnitus, and hyperacusis (a reduced tolerance to usual environmental sounds). They concluded that the principle cause of noise-induced hearing loss (NIHL) is damage to cochlear hair cells and associated cochlear synaptopathy (hidden hearing loss).
An additional study was published in 2017, stated that “blast-injured personnel are at a higher risk for hearing loss in both ears and should receive a postinjury audiometric test”. They also stated that to the best of their knowledge “this is the first report of the true hearing-shift and hearing-loss risk rate for a post-deployment, injured cohort that is based on audiometric data.”
Sources:
3M Company, 3M News Center (2012). 3M Hearing Protection Devices Now Added to the Federal Procurement List. Retrieved from https://news.3m.com/press-release/3m-hearing-protection-devices-now-added-federal-procurement-list
Centers for Disease Control and Prevention (CDC. (2011). Severe hearing impairment among military veterans–United States, 2010. MMWR. Morbidity and mortality weekly report, 60(28), 955. https://www.cdc.gov/mmwr/preview/mmwrhtml/mm6028a4.htm
Joseph, A. R., Shaw, J. L., Clouser, M. C., MacGregor, A. J., & Galarneau, M. R. (2017). Impact of blast injury on hearing in a screened male military population. American Journal of Epidemiology, 187(1), 7-15. https://doi.org/10.1093/aje/kwx199
Rempfer, K. (2018). Company to pay $9 million after allegedly selling defective combat earplugs to US military. Military Times. https://www.militarytimes.com/news/your-military/2018/07/26/company-to-pay-9-million-after-allegedly-selling-defective-combat-earplugs-to-us-military/
Theodoroff, S. M., Lewis, M. S., Folmer, R. L., Henry, J. A., & Carlson, K. F. (2015). Hearing impairment and tinnitus: prevalence, risk factors, and outcomes in US service members and veterans deployed to the Iraq and Afghanistan wars. Epidemiologic Reviews, 37(1), 71-85.
United States ex rel. Moldex-Metric v. 3M Company, Case No. 3:16-cv-1533-MBS.(2016). Retrieved from https://wwwcache.wral.com/asset/news/local/2019/01/22/18141196/15356-3M_Earplug_Complaint-DMID1-5hka47ucb.pdf
U.S. Department of Justice. (2011). The False Claims Act: A Primer. Retrieved from https://www.justice.gov/sites/default/files/civil/legacy/2011/04/22/C-FRAUDS_FCA_Primer.pdf
U.S. Department of Justice. (2018). 3M Company Agrees to Pay $9.1 Million to Resolve Allegations That it Supplied the United States With Defective Dual-Ended Combat Arms Earplugs. Retrieved from https://www.justice.gov/opa/pr/3m-company-agrees-pay-91-million-resolve-allegations-it-supplied-united-states-defective-dual
Tracy R Everhart, MSN, MS CAM
For more than 20 years I've had the opportunity to work in numerous rolls within the medical field, including the last 7 years as a professional medical writer. With an undergraduate degree in biology/microbiology, postgraduate education in allopathic and complementary alternative medicine, my education has afforded me career opportunities with direct patient care, medical research and clinical oversight of statewide projects to improve the health of patients of all ages. I have a broad and deep knowledge of illnesses and conditions that can affect the human body. Even more important is that I have learned traditional treatment methodologies combined with alternative forms, to make the most informed decision about options that may be available.
Compensation is Available for 3M Military Earplugs Lawsuits
If you or a loved one served in the military from 2003 – 2015 and experienced any hearing damage after using 3M Combat Arms Earplugs, you may be able to submit a legal claim.